Meeting Minutes for SPL Generic Sub-Team Meeting November 3, 2008, 1 pm ET These minutes along with the presentations will be posted on the Wiki at http://SPL-Work-Group.wikispaces.com. (Next Meeting Monday, October 17, 2008 at 1:00 PM ET unless cancelled) Agenda - We will be discussing the GPhA and DIA SPL Workshops in Bethesda and Philadelphia that were held this past week. 1.Lots of new members joining from GPhA meeting in Bethesda. 2.Jeffery Karp officially co-chair of generics sub-group. 3.Summary of discussion of DUNSnumbers. Tom Marsden, from Dun and Bradstreet presented at both meetings. Getting your companies DUNS number is free.Getting other companies DUNS numbers - $429 annual + $3.55 per number. We, the SPL producers, need to find the exact way of getting external/other company duns number from D&B.A flowchart with contacts would be useful. The group requests a dedicated group at D&B for these requests. Question 1 Q: Do DUNS numbers ever change? A: Rarely Lonnie joins: Question 2 Q: Will FDA help with the bulk requests of DUNS numbers? A (Lonnie): they have met with D&B and are waiting to hear from D&B with a plan. A: Virginia Hogan will follow up with D&B – meeting on Friday November 14. Question 3: Q:I understood we may use the NDC rather than the DUNS number.IS this the case? A (Lonnie):What Randy (Dr. Levin) said – the FDA strongly prefers DUNS numbers not NDCs.Please use NDC as last resort.* * I have since spoken with Lonnie and he clarified with Randy that NDC numbers will be perfectly acceptable as opposed to DUNS numbers.– Virginia Hogan Question 4 (not about DUNS number) Update of Facts@FDA Q: Will this be approved labeling? Open question
Question 5: Q: What is the order of submitting the new SPL submissions? A: Order of submissions 1.LCR – Labeler Code Request 2.ER – Electronic Site Registration 3.DL and CoL – Drug Listing and Content of Labeling Virginia described what occurred at the GPhA meeting in Bethesda, MD on October 28th.(All slides are available on the Generic Wiki page) Ann Vu presented a history of SPL. Tom Marsden presented on the DUNS Numbers. Lonnie Smith presented on SPL R4. There was a Q&A session with the FDA (Lonnie Smith, Randy Levin, Ann Vu and Koung Lee, monitored by Virginia Hogan.)The Questions and Answers will be posted to the Wiki. Some highlights: -D&B will work with Industry to put together a dedicated group to manage DUNS number requests. -D&B will not reuse DUNS numbers. -DUNS numbers are validated every 13 months -Randy announced the a site “Facts@FDA” will be set up & owned by the FDA.This will be a combination of the DailyMed and Drugs@FDA.This is a step toward the paperless labeling initiative. -You must use the gateway to submit. -Only need to send in drug listing if labeling is changed. -X-Forms will be supported indefinitely. -Industry – keep track of Marketing Dates that you have entered. -We need to be prepared – there is a huge amount of work.This is not just a pilot project, more of a transition – get your process together. -Any chance the date will be moved out?Most likely not. -What if we are not ready?Who is in charge of waivers?Randy & Lonnie are in charge of waivers, but will not use them readily. -Per Randy – “Begin Today!!!” -Talk to Lonnie if you have questions – he will gladly work one-on-one with your company. -Join the HL7 SPL Working Groups. Jeffery described what occurred at the DIA meeting in Philadelphia, on October 29thand 30th.The Phillies won the World Series. As a minor point, Lonnie Smith presented and explained how to do Labeler Code Requests Establishment Registrations Vada Perkins filled in some holes and discussed CBER. Michael Fauntleroy presented on the Electronic Submission Gateway that must be used for these submissions. Tom Marsden presented on the DUNS Numbers. There was an extended question and answer period with the FDA and SPL group leads.The questions with their answers will be posted to the Wiki.All this occurred on the first day. The second day, Gary Saner presented on some of the details of making the submissions happen including using some example files. Jeffery Karp presented the Wiki and how to use it. The afternoon was devoted to demos/presentations from six of the vendors. Attendees of this Generic Sub Team meeting on the following pages.
November 3, 2008, 1 pm ET
These minutes along with the presentations will be posted on the Wiki at http://SPL-Work-Group.wikispaces.com.
(Next Meeting Monday, October 17, 2008 at 1:00 PM ET unless cancelled)
Agenda - We will be discussing the GPhA and DIA SPL Workshops in Bethesda and Philadelphia that were held this past week.
1. Lots of new members joining from GPhA meeting in Bethesda.
2. Jeffery Karp officially co-chair of generics sub-group.
3. Summary of discussion of DUNS numbers.
Tom Marsden, from Dun and Bradstreet presented at both meetings.
Getting your companies DUNS number is free. Getting other companies DUNS numbers - $429 annual + $3.55 per number.
We, the SPL producers, need to find the exact way of getting external/other company duns number from D&B. A flowchart with contacts would be useful.
The group requests a dedicated group at D&B for these requests.
Question 1
Q: Do DUNS numbers ever change?
A: Rarely
Lonnie joins:
Question 2
Q: Will FDA help with the bulk requests of DUNS numbers?
A (Lonnie): they have met with D&B and are waiting to hear from D&B with a plan.
A: Virginia Hogan will follow up with D&B – meeting on Friday November 14.
Question 3:
Q:I understood we may use the NDC rather than the DUNS number. IS this the case?
A (Lonnie): What Randy (Dr. Levin) said – the FDA strongly prefers DUNS numbers not NDCs. Please use NDC as last resort.*
* I have since spoken with Lonnie and he clarified with Randy that NDC numbers will be perfectly acceptable as opposed to DUNS numbers. – Virginia Hogan
Question 4 (not about DUNS number)
Update of Facts@FDA
Q: Will this be approved labeling?
Open question
Question 5:
Q: What is the order of submitting the new SPL submissions?
A: Order of submissions
1. LCR – Labeler Code Request
2. ER – Electronic Site Registration
3. DL and CoL – Drug Listing and Content of Labeling
Virginia described what occurred at the GPhA meeting in Bethesda, MD on October 28th. (All slides are available on the Generic Wiki page)
Ann Vu presented a history of SPL.
Tom Marsden presented on the DUNS Numbers.
Lonnie Smith presented on SPL R4.
There was a Q&A session with the FDA (Lonnie Smith, Randy Levin, Ann Vu and Koung Lee, monitored by Virginia Hogan.) The Questions and Answers will be posted to the Wiki.
Some highlights:
- D&B will work with Industry to put together a dedicated group to manage DUNS number requests.
- D&B will not reuse DUNS numbers.
- DUNS numbers are validated every 13 months
- Randy announced the a site “Facts@FDA” will be set up & owned by the FDA. This will be a combination of the DailyMed and Drugs@FDA. This is a step toward the paperless labeling initiative.
- You must use the gateway to submit.
- Only need to send in drug listing if labeling is changed.
- X-Forms will be supported indefinitely.
- Industry – keep track of Marketing Dates that you have entered.
- We need to be prepared – there is a huge amount of work. This is not just a pilot project, more of a transition – get your process together.
- Any chance the date will be moved out? Most likely not.
- What if we are not ready? Who is in charge of waivers? Randy & Lonnie are in charge of waivers, but will not use them readily.
- Per Randy – “Begin Today!!!”
- Talk to Lonnie if you have questions – he will gladly work one-on-one with your company.
- Join the HL7 SPL Working Groups.
Jeffery described what occurred at the DIA meeting in Philadelphia, on October 29th and 30th. The Phillies won the World Series.
As a minor point, Lonnie Smith presented and explained how to do
Labeler Code Requests
Establishment Registrations
Vada Perkins filled in some holes and discussed CBER.
Michael Fauntleroy presented on the Electronic Submission Gateway that must be used for these submissions.
Tom Marsden presented on the DUNS Numbers.
There was an extended question and answer period with the FDA and SPL group leads. The questions with their answers will be posted to the Wiki. All this occurred on the first day.
The second day, Gary Saner presented on some of the details of making the submissions happen including using some example files.
Jeffery Karp presented the Wiki and how to use it.
The afternoon was devoted to demos/presentations from six of the vendors.
Attendees of this Generic Sub Team meeting on the following pages.
Generic Sub Team Attendees
For Meeting 11/03/08
Generic Sub Team Leader
OTC Team Coordinator
Distribution only
Generics Sub Team Co Leader
Distribution list only